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Ropes & Gray LLP | USA | 24 Mar 2023
What Awaits in the First Year of Medicare Drug Price Negotiations? CMS Issues Guidance and Solicits Comment on the 2026 Inflation Reduction Act Part D Negotiation Process
On March 15, 2023, the Centers for Medicare & Medicaid Services (“CMS”) issued an initial guidance memorandum (“Memorandum”) describing how it…
Skadden Arps Slate Meagher & Flom LLP | USA | 5 Jan 2023
Trend toward broader communication continues as Congress codifies life sciences companies’ ability to share product information with payors prior to FDA approval
Embedded in the thousands of pages of the Consolidated Appropriations Act of 2023 (the omnibus legislation) that President Joe Biden signed into law…
Sidley Austin LLP | USA | 29 Aug 2022
Unprecedented Changes to Medicare Programs Leave Many Questions Unanswered for Pharmaceutical Manufacturers
Earlier this month, President Biden signed into law the Inflation Reduction Act of 2022 (Act), which includes sweeping changes to the Medicare…
Kramer Levin Naftalis & Frankel LLP | USA | 30 Jul 2021
Interchangeable Biosimilars Have Arrived in the U.S.
On July 28, 2021, the Food and Drug Administration (FDA) approved the first interchangeable biosimilar product, Semglee (insulin glargine-yfgn), as a…
Hogan Lovells | USA | 16 Feb 2021
No Surprises Act prohibits balance billing, creates arbitration process for out-of-network providers
Effective January 1, 2022, the “No Surprises Act” signed into U.S. law as part of H.R. 133, “Consolidated Appropriations Act, 2021,” implicates (1)…
Sheppard Mullin Richter & Hampton LLP | USA | 29 Sep 2020
Residential Eviction Protections and California Consumer Financial Protections Pass Muster During 2020 Legislative Session
During the eleventh hour of the 2020 legislative session, the State legislature approved 2 significant bills in response to the COVID-19 pandemic…
Morrison & Foerster LLP | USA | 9 Sep 2020
Pediatric Exclusivity for Biologics
The U.S. Food and Drug Administration’s six-month pediatric exclusivity rules that apply to drugs also largely apply to biologics (albeit with…
Nexsen Pruet | USA | 18 Aug 2020
It’s time for hospitals to prepare for price transparency
In November 2019, pursuant to an Executive Order issued by President Trump in June 2019, the Centers for Medicare & Medicaid Services (CMS) published…
Kelley Drye & Warren LLP | USA | 20 Apr 2020
Finding Fevers: FDA Relaxes Rules On Temperature-Detecting Cameras
As business people, airport management, and event hosts everywhere try to figure out how they can return to business as usual, many are considering…
Hogan Lovells | USA | 25 Mar 2020
Senate bill proposes laboratory developed tests to be regulated under CLIA process
U.S. Senator Rand Paul introduced legislation that would place laboratory developed testing procedures within the Clinical Laboratory Improvement…
